Job Details

Responsibilities include: 

• Provides regulatory leadership in support of the development, registration, and life-cycle management of products by collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studies
• Lead and manage all aspects of major global marketing applications, including BLAs, NDAs, and MAAs as applicable, working with internal cross-functional teams, external consultants, and vendors to drive successful submissions, regulatory review activities, and post-submission commitments
• Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management, and Health Authority interactions. Proactively identifies regulatory risks and develops mitigation strategies to support program objectives
• Lead regulatory planning for major milestones, including INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.
• Lead and manage interactions with FDA, EMA, and other global Health Authorities, including development of regulatory strategies, briefing documents, meeting preparation, meeting leadership, and regulatory correspondence
• Monitor and interpret evolving global regulatory requirements, guidance, and industry trends impacting development, registration, and commercialization activities, and communicate implications to cross-functional stakeholders.
• Manage day to day reports, submissions, requests for products
• Recruit, mentor, develop, and manage regulatory professionals and consultants to ensure organizational excellence and successful execution of corporate objectives.
• Other duties as required.

Education, Experience, and Skills: 
Required: 
 

• PhD/PharmD with 12+ years’ experience in Regulatory Affairs or BS/MS/MSN with 14+ years’ experience.    
• Demonstrated experience leading major marketing application submissions (e.g., BLA, NDA, and/or MAA), including regulatory strategy development, submission execution, and regulatory review activities
• Proven ability to influence senior leadership and cross-functional stakeholders through strategic regulatory guidance, effective communication of complex regulatory issues, and proactive risk assessment and mitigation.
• Experience working directly with the FDA and EMA. In-depth knowledge of FDA and EMA regulations and CTD/eCTD requirement
• Excellent regulatory writing and review skills with demonstrated experience authoring and overseeing high-quality regulatory submissions and Health Authority communications.
• Understands the regulatory environment for biotech companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements.
• Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
• Experience supporting development of biologics and/or small molecules, preferably in rare disease, immunology, and/or neuroscience,
• Possesses leadership skills and ability to interact with outside vendors and partner companies.

Comp $265-285K based on experience